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FDA Approves Prescription Strength Pepcid AC (famotidine 20 mg) for Over-The-Counter Treatment of Heartburn

FORT WASHINGTON, PA -- September 25, 2003 -- Johnson & Johnson-Merck Consumer Pharmaceuticals Company announced today the approval by the U.S. Food and Drug Administration (FDA) of Maximum Strength PepcidŽAC (famotidine 20 mg) for over-the-counter (OTC) usage. The highest famotidine dosing now available without a prescription, Maximum Strength Pepcid AC is a strong and effective choice for treating heartburn associated with acid indigestion and sour stomach.

"We are extremely pleased with the FDA approval of Maximum Strength Pepcid AC," said Renaat Van den Hooff, Worldwide President, Johnson & Johnson-Merck. "Since our initial Rx to OTC switch in 1995, the Pepcid Brand has provided a variety of options for heartburn sufferers. We are delighted that we can now offer our prescription strength Pepcid AC over-the-counter to meet the needs of those heartburn sufferers who require stronger treatment options."

New Maximum Strength Pepcid AC's patented formula is double the strength (famotidine 20 mg) of Original Pepcid AC (famotidine 10 mg). Maximum Strength Pepcid AC will be available in packages of 5, 25, 50 and 75 tablets at retail food stores, pharmacies and mass merchandisers nationwide this October. The Pepcid AC family of products will continue to be available in original tablet, chewable and gel cap formulations.

"This is great news for occasional heartburn sufferers," said Steven R. Peikin, M.D., head of Gastroenterology and Department of Liver Disease at Cooper Hospital/University Medical Center and professor of medicine at Robert Wood Johnson Medical School and author of Gastrointestinal Health. "Maximum Strength Pepcid AC provides effective prescription strength relief, and continues to offer heartburn sufferers the choice to take a heartburn remedy only when needed."

Heartburn occurs as a result of inappropriate relaxation of the muscular valve at the lower end of the esophagus, or food pipe. This valve normally serves to keep acidic juices in the stomach. Heartburn strikes when acid from the stomach flows up into the esophagus causing a burning sensation in the chest or throat, sometimes leaving a sour or bitter taste in the mouth. Certain foods may trigger heartburn such as coffee, fatty foods, chocolate, peppermint and alcohol. Heartburn can usually be treated and prevented through lifestyle modifications, as well as with medication.

The Pepcid Franchise has had an important presence in the acid relief category since 1995, and continues to be the choice of millions of consumers. Pepcid provides effective and long-lasting relief, which lasts all day or all night, only when needed. Pepcid AC prevents heartburn when taken before meals and Pepcid Complete's superior Dual Action formula stops heartburn and acid indigestion after it starts. Pepcid Complete's fast-acting antacid starts neutralizing acid on contact while the H2 blocker, found in Pepcid AC, prevents the production of excess acid at the source, to provide fast, long-lasting, all day or all night relief* with just one dose.

Maximum Strength Pepcid AC is the newest product from Johnson &

Johnson-Merck Consumer Pharmaceuticals Co., a joint venture between two of the nation's largest healthcare companies. The company combines the clinical research and development capabilities of Merck and Co., with the consumer marketing and sales expertise of Johnson & Johnson. The company is based in Fort Washington, PA.

* Based on 8 hour symptom relief studies during the day and 12 hour acid control studies at night.


SOURCE: Johnson & Johnson-Merck Consumer Pharmaceuticals Company

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